Circular No. 14/2016/TT-BNNPTNT on animal disease safety zones and facilities

CIRCULAR

Regulations on disease-free zones and establishments for animals

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Based on the Law on Veterinary Medicine dated June 19, 2015;

On the basis of Decree No. 199/2013/NĐ-CP dated November 26, 2013 of the Government stipulates the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

At the proposal of the Director of the Animal Health Department,

The Minister of Agriculture and Rural Development promulgates this CircularPursuant to the Circular concerning disease-free zones and establishments for animals.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

Article 1. This Circular stipulates the conditions, procedures, formalities, and documentation for certifying disease-free zones and establishments for animals.

Article 2. This Circular applies to organizations and individuals within the country and foreign organizations and individuals who have the need to construct, register, and obtain certificates for disease-free zones and establishments for animals in Vietnam; relevant agencies and organizations.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Disease-free zone for terrestrial animals is a district, town, city under province (hereinafter referred to collectively as district level); province, centrally governed city (hereinafter referred to collectively as provincial level) determined not to have cases of registered diseases during a specified period for each disease and each animal species, and veterinary activities in the area ensure disease control.

2. Disease-free establishment for terrestrial animals is a livestock farm or a commune, ward, town (hereinafter referred to as a commune-level livestock farm) determined not to have cases of registered diseases during a specified period for each disease and each animal species, and veterinary activities at the establishment ensure disease control.

3. Disease-free zone for aquatic animals is a group of establishments or households engaged in aquaculture in the same area with shared water sources, determined not to have cases of registered diseases during a specified period for each disease and each aquatic animal species, and veterinary activities in the area ensure disease control.

4. Disease-free establishment for aquatic animals is a production and breeding establishment for aquatic animals determined not to have cases of registered diseases during a specified period for each disease and each aquatic animal species, and veterinary activities at the establishment ensure disease control.

5. Biosecurity refers to technical measures applied to prevent contact and spread of pathogens that occur naturally or are caused by humans in livestock farming, breeding, and aquaculture activities, thereby preventing pathogens from entering and causing harm to animals within the establishment or zone.

6. Animal disease surveillance involves monitoring, inspecting, and evaluating animal health; observing livestock farming, breeding, and aquaculture processes, and the environment to detect early risk factors and pathogens, providing warnings, and effectively applying preventive and control measures.

Article 3. Assessment and Issuance of Certificates for Disease-Free Zones and Establishments

Clause 1. The Department of Animal Health organizes the assessment and issuance of certificates for disease-free zones for terrestrial animals and disease-free zones for aquatic animals; assesses and issues certificates for disease-free establishments for livestock farms, commune-level livestock farms, aquaculture establishments, and aquatic animal breeding establishments based on the requirements of the establishment owners or import countries; parent aquatic animal breeding establishments.

Clause 2. The provincial veterinary management agency (hereinafter referred to as the Provincial Veterinary Service) organizes the assessment and issuance of certificates for disease-free establishments for livestock farms, commune-level livestock farms, aquaculture establishments, and aquatic animal breeding establishments, except for the cases stipulated in Clause 1 of this Article. The agency responsible for assessing and issuing certificates for disease-free zones and establishments for animals is hereinafter referred to collectively as the Veterinary Agency.

Article 4. Fees and Charges

The collection of fees and charges for issuing certificates for disease-free zones and establishments shall be carried out in accordance with current laws.

Article 5. Benefits of Disease-Free Zones and Establishments

1. Enjoy benefits as prescribed in Clause 2 of Article 17, Clause 2 of Article 39, and Clause 2 of Article 55 of the Law on Animal Health.

2. For animal disease-free zones and establishments: Permitted to transport animals and animal products out of the epidemic area in accordance with Circular No. 07/2016/TT-BNNPTNT dated May 31, 2016 issued by the Minister of Agriculture and Rural Development on prevention and control of terrestrial animal diseases, and in accordance with the guidance of the specialized veterinary management agency.

3. For aquatic animal disease-free zones and establishments: Considered for selling commercial aquatic animals without preliminary processing when there is a disease announcement at the local level in accordance with Circular No. 04/2016/TT-BNNPTNT dated May 10, 2016 issued by the Minister of Agriculture and Rural Development on prevention and control of aquatic animal diseases (hereinafter referred to as Circular No. 04/2016/TT-BNNPTNT).

4. Considered for certification of compliance with Good Animal Husbandry Practices (VietGAHP) or Good Aquaculture Practices (VietGAP) when requested.

5. Given priority to participate in trade promotion programs and product promotion.

Chapter II

DISEASE-FREE ZONES AND ESTABLISHMENTS FOR TERRESTRIAL ANIMALS

Section 1

Requirements for disease-free animal establishments

Article 6. Requirements that must be met for terrestrial animal breeding establishments to be certified as disease-free

1. Implement requirements for the prevention and control of terrestrial animal diseases as stipulated in Article 7 of this Circular.

2. Conduct disease surveillance of animals in accordance with Article 8 of this Circular.

3. No occurrence of animal diseases as stipulated in Article 9 of this Circular.

4. Veterinary activities at the establishment must be conducted in accordance with Articles 14, 15, Clause 1 of Article 19, Article 20, Clause 1 of Article 25, Clause 9 of Article 27, Clause 3 of Article 28, Clause 2 of Article 29, and Clause 6 of Article 30 of the Law on Animal Health and the provisions of this Circular.

Article 7. Requirements for the Prevention and Control of Terrestrial Animal Diseases at Establishments

1. Village-level breeding establishments must comply with the provisions of Article 11 of this Circular.

2. Breeding establishments must comply with the provisions of Article 14 and Clauses 1, 2, 3, and 4 of Article 15 of the Law on Animal Health, specifically as follows:

a) The breeding site must follow the local planning or be approved by the competent authority, ensuring separation from residential areas, public facilities, main roads, and pollution sources.

b) There must be an area for waste treatment, isolation of animals, and hygiene and disinfection areas for livestock equipment.

c) Production, processing, and storage areas for feed must be separated from hazardous chemical areas and waste treatment areas.

d) Measures must be taken to prevent other animals from entering the breeding area.

đ) Entry and exit points to the breeding area must apply hygiene and disinfection measures for people and transportation vehicles passing through.

e) Livestock equipment, tools, and transportation vehicles used within the establishment must be cleaned, disinfected, and decontaminated before being brought into the establishment and before use.

g) Water used for breeding must meet the National Technical Regulation QCVN 01 - 39: 2011/BNNPTNT (issued together with Circular No. 33/2011/TT-BNNPTNT dated May 16, 2011 by the Minister of Agriculture and Rural Development) on the hygiene of water used for breeding or has been treated to eliminate dangerous infectious agents in animals.

h) Livestock waste must be collected and treated in accordance with laws on environmental protection and animal health.

i) Implement mandatory preventive measures for farmed animals as prescribed by the Ministry of Agriculture and Rural Development.

3. Animals sensitive to the registered disease when introduced into breeding establishments must meet one of the following requirements:

a) Originating from a disease-free zone or establishment for the registered disease.

b) Having been tested and examined by a designated laboratory with the capability to test the registered disease, confirming they do not carry the causative agent of the disease or have antibodies due to natural infection for the registered disease.

c) Having been vaccinated against the registered disease and still having protective immunity.

Article 8. Requirements for disease surveillance of terrestrial animals at facilities

1. Livestock facilities must conduct clinical monitoring of animals throughout the rearing process to detect signs of infectious diseases. In cases where there is suspicion that animals have contracted infectious diseases, they must report to the veterinary authority to take samples for testing to determine the causative agent.

a) Regularly observe and record the health status of the livestock herd once a week through the amount of feed consumed, unusual respiratory, digestive, movement, behavioral symptoms of the animals, and other abnormal manifestations.

b) Record and retain all information related to disease prevention, treatment, and epidemic control for animals, including: Type of vaccine used, date of vaccine administration; hygiene, disinfection, and sterilization activities, type of disinfectant; time of onset of the disease, symptoms of the disease, number of animals affected each day, veterinary drugs used, start date of drug use for animal treatment, measures taken for diseased animals; type of sample, quantity of samples sent for testing, date of sample submission, and test results (if available).

2. Sampling and testing for registered safe diseases shall be carried out according to the following requirements:

a) Apply random sampling methods based on statistical probability; for village-level livestock facilities, apply sampling methods as guided in Appendix IV issued together with this Circular;

b) Facilities not applying disease prevention measures using vaccines: Conduct disease surveillance to detect pathogens or detect antibodies due to natural infection; the number of surveillance samples (or number of animals tested) shall comply with the provisions in Section A of Appendix IV issued together with this Circular; test results must ensure that 100% of samples are negative (no pathogen or no antibodies due to natural infection) for registered safe diseases; for Tuberculosis, test 100% of the animals and the test results must ensure 100% negativity;

c) Facilities applying disease prevention measures using vaccines: Conduct post-vaccination surveillance to evaluate immune response; the number of post-vaccination surveillance samples shall comply with the provisions in Section B of Appendix IV issued together with this Circular; test results must ensure that more than 70% of samples have antibodies at protective levels for registered safe diseases; In cases where post-vaccination surveillance results do not meet requirements or post-vaccination surveillance is not conducted, the facility may apply disease surveillance to detect pathogens or detect antibodies due to natural infection as stipulated in point b of this clause;

d) The Regional Veterinary Authority shall carry out one sample testing to conduct proactive surveillance for facilities under management as prescribed in Clause 1, Article 3 of this Circular;

đ) The Provincial Veterinary Service shall carry out one sample testing to conduct proactive surveillance for facilities under management as prescribed in Clause 2, Article 3 of this Circular;

e) Sampling, preservation, and transportation of samples shall follow QCVN No. 01 - 83: 2011/BNNPTNT issued together with Circular No. 71/2011/TT-BNNPTNT dated October 25, 2011 of the Minister of Agriculture and Rural Development;

g) Samples must be tested at designated laboratories; intradermal reaction tests shall be conducted by the Veterinary Authority;

h) Proactive surveillance testing methods shall be carried out in accordance with current regulations in the Vietnamese Standard - Diagnostic Procedures for Animal Diseases for specific diseases registered for safety certification;

3. Livestock facilities are responsible for immediately notifying local authorities and the Provincial Veterinary Service when test results confirm that animals are carrying pathogens listed in the List of Notifiable Animal Diseases and the List of Zoonotic Diseases; simultaneously, they must implement measures as prescribed by the Ministry of Agriculture and Rural Development for the prevention and control of terrestrial animal diseases.

4. Facilities granted a Certificate of Disease Safety must maintain their conditions in accordance with the provisions of Clause 3, Article 50 of this Circular.

Article 9. Requirements for the animal disease status at the facility

1. For facilities applying for the first time for a Certificate: There have been no cases of the registered safe disease within at least 12 (twelve) months prior to the submission of the application.

2. For facilities whose Certificate has expired according to points a and d, Clause 1, Article 47 of this Circular or facilities reapplying for a Certificate: There have been no clinical cases of the registered safe disease at the time of resubmission of the application.

3. For facilities whose Certificate has expired according to points b and c, Clause 1, Article 47 of this Circular: There have been no cases of the registered safe disease within at least 03 (three) months from the date when the last diseased animal was treated or recovered.

Section 2

YRequirements for the terrestrial animal disease-free zone

Article 10. Requirements to be met for a terrestrial animal breeding area to be certified as disease-free

1. Implement the requirements for prevention and control of animal diseases stipulated in Article 11 of this Circular.

2. Conduct animal disease surveillance as prescribed in Article 12 of this Circular.

3. No outbreaks of animal diseases as specified in Article 13 of this Circular.

4. Veterinary activities in the area must be carried out in accordance with Articles 14, 15, 19, 20, 25, and 30 of the Law on Animal Health and the provisions of this Circular; surrounding communes adjacent to the disease-free area must implement preventive and control measures against animal diseases as prescribed by the law on animal health.

Article 11. Requirements for prevention and control of terrestrial animal diseases in the area

1. Breeding facilities in the area must implement disease prevention and control measures as prescribed in Article 7 of this Circular.

2. In the case of establishing a disease-free area using vaccines, a vaccine usage plan for the registered safe disease must be developed and implemented according to Clause 5, Article 15 of the Law on Animal Health. The Animal Health Service must develop, submit for approval by the competent authority, and organize the implementation of the vaccine usage plan in the locality.

3. Develop and implement a disease surveillance program for the registered safe disease as prescribed in Article 12 of this Circular.

Article 12. Requirements for surveillance of terrestrial animal diseases in the area

1. Breeding facilities in the area must conduct surveillance as prescribed in Article 8 of this Circular.

2. The Animal Health Service must develop a disease surveillance program for the registered safe disease in the locality, send it for comments to the Central Animal Health Office, submit it for approval by the competent authority, and organize the implementation of the disease surveillance program.

3. The contents of the disease surveillance program include:

a) Surveillance methods: Clinical surveillance, post-vaccination surveillance, or surveillance to detect the presence of pathogens of the registered safe infectious disease;

b) Sampling method, sample type, number of samples, sampling frequency, and testing of samples;

c) Collection, management, and analysis of information and data;

d) Measures to handle surveillance results.

4. Within 15 (fifteen) days from receiving the request document from the Animal Health Service, the Central Animal Health Office sends its professional opinion on the disease surveillance program of the locality.

Article 13. Requirements for disease status in terrestrial areas within the region

1. For regions applying for certification for the first time: There must be no cases of the registered safe disease in at least 12 (twelve) months prior to the date of submitting the application.

2. For regions whose certificate has expired according to points a and d, Clause 1, Article 47 of this Circular or regions reapplying for certification: There must be no clinical cases of the disease certified as safe in the region at the time of resubmitting the application.

3. For regions whose certificate has expired according to points b and c, Clause 1, Article 47 of this Circular: There must be no cases of the disease certified as safe in at least 03 (three) months from the date of the last infected animal being destroyed or recovered.

Chapter III

ZONE, SAFE DISEASE ESTABLISHMENTS FOR AQUATIC LIVESTOCK

Section 1

Requirements for safe disease establishments for aquatic livestock

Article 14. Requirements that must be met for production and breeding establishments, aquaculture farms to be certified as safe from diseases

1. Implement the requirements for prevention and control of aquatic livestock diseases stipulated in Article 15 of this Circular.

2. No outbreaks of aquatic livestock diseases as defined in Article 16 of this Circular.

3. Develop and implement a disease surveillance plan for aquatic livestock as prescribed in Articles 17, 18, 19, 20, and 21 of this Circular.

4. Veterinary activities at the establishment must be carried out in accordance with Articles 14, 15, 19, 20, 32, 33, and 35 of the Law on Animal Health, the provisions of Circular No. 04/2016/TT-BNNPTNT, and the provisions of this Circular.

Article 15. Requirements for prevention and control of aquatic livestock diseases at the establishment

1. Aquatic livestock breeding establishments must comply with the provisions of Article 14 and Clauses 1, 2, 3, and 4 of Article 15 of the Law on Animal Health and Circular No. 04/2016/TT-BNNPTNT, with specific contents as follows:

a) Water used in aquatic livestock breeding must be treated to ensure it does not carry pathogens and does not affect the health of aquatic animals;

b) Apply appropriate measures to protect and prevent the entry of invasive species into the breeding and farming areas; ensure that water does not leak from the holding areas of aquatic animals into the external environment and vice versa;

c) Imported aquatic livestock breeding stock must have origins from regions or establishments certified as safe from diseases or negative test results from designated laboratories for the disease being monitored by the establishment; they must be inspected in accordance with current regulations;

d) Have internal rules and hygiene procedures for each production stage, management, and use of materials; procedures for handling when diseases occur at the establishment; perform sanitation, disinfection, and decontamination of production tools before and after use, personal hygiene for those involved in production, buying and selling, transportation, visiting, and vehicles entering the establishment;

đ) Those directly involved in breeding aquatic livestock must have knowledge about the diseases being monitored and registered for safe disease certification by the establishment;

e) Have a designated laboratory or contract with a designated laboratory capable of testing for the disease being registered for safe disease certification by the establishment.

2. Aquatic livestock commercial farming establishments must comply with the provisions of Article 14 and Clauses 1, 2, 3, and 4 of Article 15 of the Law on Animal Health and meet the following requirements:

a) Those directly involved in farming aquatic livestock must have knowledge about the diseases being monitored;

b) Meet the requirements specified in points a, b, c, d, and e of Clause 1 of this Article.

3. Aquatic livestock ornamental breeding and farming establishments must comply with the provisions of Article 14 and Clauses 1, 2, 3, and 4 of Article 15 of the Law on Animal Health and meet the following requirements:

a) For ornamental aquatic livestock breeding establishments: Apply conditions as prescribed in Clause 1 of this Article;

b) For ornamental aquatic livestock farming establishments: Apply conditions as prescribed in Clause 2 of this Article;

c) For breeding and farming establishments equipped with glass tanks for holding aquatic animals, these tanks must be regularly cleaned, disinfected, and decontaminated before and after use.

Article 16. Requirements for the animal health status at the facility

1. For facilities applying for the first time to obtain a Certificate: There must be no aquatic animals suffering from the diseases listed for safe certification in the application documents for at least six (6) months prior to submission.

2. For facilities whose Certificates have expired according to points a and d, Clause 1, Article 47 of this Circular or facilities reapplying for a Certificate: There must be no aquatic animals suffering from the diseases certified as safe at the time of resubmission of the application documents.

3. For facilities whose Certificates have expired according to points b and c, Clause 1, Article 47 of this Circular: There must be no aquatic animals suffering from the diseases certified as safe in the facility's holding area for at least six (6) months following the destruction of the last diseased aquatic animal holding area or following the completion of treatment of diseased aquatic animals.

Article 17. Development of Disease Surveillance Plan for Aquatic Animals at the Facility

Facilities seeking disease safety certification for aquatic animals must develop and implement a Disease Surveillance Plan (hereinafter referred to as the Surveillance Plan), including:

1. Proactive Surveillance

a) Monitoring and recording information on activities ensuring disease safety in aquaculture production and breeding; preventive and control measures against diseases;

b) Monitoring and recording information on production and breeding conditions, disease situations, veterinary drug usage, environmental improvement products, and environmental management; feed usage, veterinary hygiene measures, and disease management;

c) Collecting samples of farmed aquatic animals, environmental samples, waste samples, live feed samples (if applicable), and intermediate host samples for testing to identify pathogens as specified in Article 19 of this Circular.

2. For facilities already certified under VietGAP, the facilities must develop the Surveillance Plan according to point c, Clause 1, and Clauses 3, 4, 5, and 6 of this Article.

3. Subjects Under Surveillance

a) Infected, suspected infected, symptomatic, or diseased aquatic animals;

b) Aquatic animals currently being raised at the facility or newly introduced to the facility;

c) Feed used for aquatic animals;

d) Environment, waste, and disease transmission factors;

đ) Diseases and pathogens proposed for safe certification by the facility.

4. Surveillance Locations

a) Breeding, nursery, and farming areas for aquatic animals; quarantine areas for aquatic animals, feed storage areas; water supply sources, waste collection areas, and wastewater discharge areas;

b) Areas suspected of having disease, areas previously affected by disease outbreaks, and areas at risk of disease outbreaks.

5. Reactive surveillance is conducted upon request by the Veterinary Authority and when there is suspicion of disease occurrence at the facility.

6. Steps for Developing the Surveillance Plan

a) Determining the objectives of surveillance to detect pathogenic agents;

b) Reviewing, inspecting, and supplementing necessary resources, including: Sampling tools, sample preservation, transportation, and processing equipment; laboratory capacity, equipment, chemicals, and testing tools; testing procedures; information recording, management, data analysis, and testing result systems; necessary human resources and funding for implementation of surveillance;

c) Detailed contents for conducting surveillance; assignment of responsibilities to relevant units and individuals, and timelines for each component of the Plan;

d) Submitting the Surveillance Plan to the Veterinary Authority as stipulated in Article 3 of this Circular.

Article 18. Implementation of the Supervision Plan at the Facility

1. The facility that has registered for certification of disease safety shall proactively implement the Supervision Plan submitted to the Veterinary Authority.

2. Timeframe for implementing the Supervision Plan:

a) For facilities applying for the first time for a Certificate of Registration: At least two years from the date of submitting the application for the Certificate of Registration. During the implementation of the Supervision Plan, if any disease pathogens registered for safety certification are detected, the facility must continue to implement the Supervision Plan for at least six months for aquaculture seed production facilities and at least three months for commercial aquaculture facilities compared to the initial Supervision Plan.

b) For facilities with expired Certificates according to points b, c, and d, Clause 1, Article 47 of this Circular: Implement supervision for a minimum period of six months from the date the Certificate expires. The content of the supervision must be consistent with the content of the Supervision Plan previously implemented before obtaining the Certificate.

3. When there are adjustments to the timeframe, sample quantity, or sampling frequency compared to the Supervision Plan submitted to the Veterinary Authority, the facility must submit a report explaining the reasons for the adjustment along with the adjusted Supervision Plan.

4. Upon completion of the supervision process, the facility must compile, analyze data, evaluate results, assess the situation, and prepare a supervision result report in accordance with Article 21 of this Circular.

Article 19. Sampling

1. Principles of sampling:

a) Must be based on the surveillance objectives to detect diseases and pathogens and apply probability sampling methods;

b) The number of samples for monitoring is specified in Appendix V issued together with this Circular.

2. Frequency of sampling:

a) For aquaculture seed production facilities, sampling must be conducted at least once every one month;

b) For commercial aquatic animal farming facilities, sampling must be conducted at least once every three months.

3. The facility must collect, store, and test the samples or send them to the designated laboratory for testing in accordance with point e, Clause 1, Article 15 of this Circular.

4. Sampling, storage, and transportation of monitoring samples: To be carried out in accordance with QCVN 01-83:2011/BNNPTNT (issued together with Circular No. 71/2011/TT-BNNPTNT dated October 25, 2011 of the Minister of Agriculture and Rural Development).

Article 20. Testing Samples

1. Within five working days from receiving the samples, the designated laboratory must provide the test results to the facility.

2. Handling of test results:

a) In case the test results are negative: The facility may use these results to apply for a Certificate of Disease Safety Facility after completing the Supervision Plan;

b) In case the test results are positive: The facility must implement disease prevention and control measures in accordance with Circular No. 04/2016/TT-BNNPTNT.

3. Within two working days from receiving the notification from the facility as stipulated in point b, Clause 2 of this Article, the Animal Health Sub-Department must dispatch staff to the facility to coordinate and guide the following actions:

a) Isolate ponds or tanks with positive test samples; conduct clinical examinations of all remaining ponds or tanks at the facility, and if signs of disease are found, implement disease control measures in accordance with Circular No. 04/2016/TT-BNNPTNT;

b) Collect and retest samples if there is suspicion or at the request of the facility: If the retest results are negative, the facility must follow the provisions of point a, Clause 2, Article 18 of this Circular. If the retest results are positive, the facility must implement disease prevention and control measures in accordance with Circular No. 04/2016/TT-BNNPTNT.

Article 21. Contents of the report on the results of supervision at the facility

1. The situation of aquaculture production during the implementation of the Supervision Plan, including activities of exporting and importing aquatic animals to and from the facility.

2. The situation of animal diseases at the facility during the implementation of the Supervision Plan.

3. Passive surveillance results: Time, location of detecting abnormal signs in aquatic animals, number of samples taken, testing criteria including the environment and disease samples with test results, and disease outbreak handling results.

4. Active surveillance results:

a) Disease inspection: Number of points, position, time of sample collection at the facility, type of sample, number of samples, sampling principles as stipulated in Articles 17, 18, and 19 of this Circular, along with test results of the samples and handling of test results according to Clause 2, Article 20 of this Circular;

b) Environmental inspection for breeding: Number of points, position, time of sample collection at the facility, type of sample, number of samples per collection, testing criteria, and test results;

c) Record contents: For seed production facilities, record contents as prescribed in Circular No. 26/2013/TT-BNNPTNT dated May 25, 2013 of the Minister of Agriculture and Rural Development on seed management; for commercial aquatic animal breeding facilities, record contents as prescribed in Appendix IX issued together with this Circular.

5. The status of animal diseases as stipulated in Article 16 and veterinary activities at the facility as stipulated in Clause 4, Article 14 of this Circular.

Section 2

Requirements for disease-free zones for aquatic animals

Article 22. Requirements to be met for aquaculture zones to be certified as disease-free

1. Implement requirements for disease prevention and control for aquatic animals as stipulated in Article 23 of this Circular.

2. No occurrence of diseases among aquatic animals as stipulated in Article 24 of this Circular.

3. Develop and implement the Surveillance Plan for aquatic animal diseases as stipulated in Articles 25 and 26 of this Circular.

4. Veterinary activities within the zone must be carried out in accordance with Articles 14, 15, 19, 20, 32, 33, and 35 of the Law on Animal Health, provisions in Circular No. 04/2016/TT-BNNPTNT, and provisions in this Circular.

Article 23. Requirements for disease prevention and control in aquatic animal zones

1. Aquaculture facilities or households in the zone applying for certification as a disease-free zone for aquatic animals must comply with the provisions of Article 15 of this Circular and the following provisions:

a) The use of water supply or discharge of wastewater through common channels must be treated to ensure disease safety.

b) In cases where all households and facilities in the zone purchase seed from the same production batch from one facility: Use a shared Health Certificate or have representatives of facilities in the zone (hereinafter referred to as the Zone Representative) register for inspection and testing (in cases of purchasing seed locally).

c) In cases not covered by point b of this clause, imported seed for each household must originate from a facility certified as disease-free or must have negative test results from a designated laboratory for the disease being monitored by the zone.

d) Uniformly implement breeding log recording using the same form that meets current regulations.

đ) Coordinate with the Zone Representative to develop and organize the implementation of the Surveillance Plan as stipulated in Articles 25 and 26 of this Circular.

2. Regularly convene meetings between facilities and households in the zone to report progress and subsequent plans. Any adjustments to the Surveillance Plan must be compiled and reported to the Department of Animal Health by the Zone Representative.

Article 24. Requirements for the animal health status in the region

1. For regions applying for the first time to obtain a Certificate: There must be no aquatic animals suffering from the registered safe diseases for at least six months prior to the submission of the application.

2. For regions whose Certificate has expired according to points a and d, Clause 1, Article 47 of this Circular or regions reapplying for a Certificate: There must be no aquatic animals suffering from the registered safe diseases at the time of resubmission of the application.

3. For regions whose Certificate has expired according to points b and c, Clause 1, Article 47 of this Circular: There must be no aquatic animals suffering from the registered safe diseases for at least six months since the last infected pond or holding place within the region was destroyed or since the diseased aquatic animals and their holding places were properly disposed of.

Article 25. Establishment and Implementation of Disease Surveillance Plans in the Region

1. Entities within the region shall appoint a Regional Representative to implement the surveillance program and complete the procedures for obtaining a Certificate of disease safety.

2. The Regional Representative is responsible for leading and coordinating the implementation of the Surveillance Plan as stipulated in Articles 17, 18, 19, and 20 of this Circular.

3. Regarding sampling locations: In addition to the locations specified in Clause 4, Article 17 of this Circular, samples must also be collected from common areas, water supply and drainage channels of the breeding region, and high-risk areas where the registered diseases may appear.

Article 26. Content of Surveillance Reports in the Region

1. For entities within the region applying for disease safety certification: Follow the provisions set out in Article 21 of this Circular.

2. For regions applying for disease safety certification, the Regional Representative shall compile reports from breeding entities within the region, including the following contents:

a) Production and aquaculture situation, including the import and export of aquatic animals into and out of the region;

b) Disease situation among aquatic animals in the region;

c) Passive surveillance results;

d) Active surveillance results;

đ) Animal health status according to Article 24 and veterinary activities in the region as stipulated in Clause 4, Article 22 of this Circular.

Chapter IV

PROCEDURE, PROCEDURES, AND APPLICATION DOCUMENTS FOR REGIONAL CERTIFICATION,

SAFE DISEASE AREAS

Section 1

Animal Disease Safety Entity

Article 27. Application Documents

1. The entity head shall prepare and submit one set of application documents for disease safety certification directly or via postal mail or email to the Veterinary Authority as stipulated in Article 3 of this Circular. The documents include:

a) Application form (Annex VIa);

b) Report on the conditions of terrestrial animal disease safety facilities (Annex IIa) or Report on the conditions of aquatic animal disease safety facilities (Annex VII);

c) Report on surveillance results conducted as prescribed in Article 8 or Article 21 of this Circular;

d) Copy of valid facility inspection and classification results (if applicable) pursuant to Decree No. 45/2014/ND-BNNPTNT dated December 3, 2014 of the Minister of Agriculture and Rural Development on the inspection of agricultural inputs production and business establishments and the inspection and certification of agricultural, forestry, and aquatic products production and business establishments meeting food safety requirements (hereinafter referred to as Decree No. 45/2014/ND-BNNPTNT);

đ) Copy of valid VietGAHP Certificate (for terrestrial animal breeding facilities) or VietGAP Certificate (for seed production and commercial aquatic animal breeding facilities) (if applicable).

2. For village-level breeding facilities, the Chairman of the People's Committee of the commune shall submit one set of application documents directly or via postal mail or email to the Veterinary Authority, which includes:

a) Request letter (Annex VIb);

b) Report on the conditions of terrestrial animal disease safety facilities for village-level breeding facilities (Annex IIb);

c) Report on surveillance results conducted as prescribed in Article 8 of this Circular.

Article 28. Acceptance and Processing of Registration Files

Within five (5) working days from the date of receipt of the file, the Veterinary Authority shall check the validity and assess the contents of the file.

1. In case the file is valid, the Veterinary Authority shall establish an Inspection and Evaluation Team (hereinafter referred to as the Evaluation Team) and notify the inspection and evaluation plan to the facility.

2. In case the file is invalid, the Veterinary Authority shall notify the facility in writing to make corrections, supplements, and improvements.

Article 29. Composition of the Evaluation Team and Evaluation Period

1. The Evaluation Team shall consist of at least three (3) members. The team leader shall be a leader of the Veterinary Authority or a specialist department leader of the Veterinary Authority, and the members shall be specialized staff of the Veterinary Authority.

2. Within ten (10) working days from the date of establishment, the Evaluation Team must conduct inspections and evaluations at the facility.

Article 30. Contents of Inspections and Evaluations at the Facility

1. For facilities with a VietGAP Certificate or aquaculture production facilities that have been inspected and classified as type A or type B according to Circular No. 45/2014/TT-BNNPTNT, the inspection contents include:

a) Knowledge and practice of individuals directly involved in aquaculture production regarding signs of disease and handling situations when the facility experiences registered diseases for certification;

b) Current health status of animals; implementation of measures to control and prevent disease risks from both outside and inside the facility;

c) Results of implementing the monitoring plan as stipulated in Article 18 of this Circular;

d) Results of managing veterinary activities at the facility as stipulated in Clause 4, Article 14 of this Circular.

2. For facilities with a VietGAHP Certificate or livestock breeding facilities that have been inspected and classified as type A or type B according to Circular No. 45/2014/TT-BNNPTNT, the inspection shall cover the implementation of monitoring activities as stipulated in Article 8 of this Circular.

3. For facilities without a VietGAHP or VietGAP Certificate or those that have been inspected but not met requirements according to Circular No. 45/2014/TT-BNNPTNT, the following actions shall be taken:

a) For land animal breeding facilities: Inspection contents shall be carried out according to Clauses 1, 2, 3, and 4 of Article 6 of this Circular. The inspection and evaluation report at the facility shall be conducted according to Appendix Ia issued together with this Circular;

b) For seed production and aquaculture facilities: Inspection contents shall be carried out according to Clause 1 of this Article and Article 15 of this Circular.

4. During the inspection process:

a) For land animal breeding facilities: Samples shall be collected and sent to designated laboratories for testing of registered disease safety. The test result report shall be supplemented by the Veterinary Authority into the facility's disease safety registration file;

b) For seed production and aquaculture facilities that do not meet hygiene requirements, the Evaluation Team shall collect samples and send them to designated laboratories for testing.

5. At the end of the inspection, the Evaluation Team shall prepare a record according to the model in Appendix Ia, Appendix VIIIa, or Appendix VIIIb issued together with this Circular; notify the inspection results to the facility owner, and simultaneously report the inspection results to the leadership of the Veterinary Authority as stipulated in Article 3 of this Circular.

6. For village-level breeding facilities, the inspection contents shall be carried out according to Article 36 of this Circular.

Article 31. Issuance of Certificate

1. Within five (5) working days from the date of completion of inspection at the facility or from the date of receipt of the test results for diseases as prescribed in Clause 3, Article 30 of this Circular, the Veterinary Authority shall issue a Certificate to facilities that meet the requirements; in cases where a Certificate is not issued, the Veterinary Authority must provide a written response specifying the reasons and guiding the facility on how to address the non-compliant elements.

2. Model of the Animal Disease Safety Certificate:

a) The Department of Animal Health issues certificates according to the model prescribed in Appendix X attached to this Circular or as required by the importing country.

b) The District Animal Health Office issues certificates according to the model prescribed in Appendix XI attached to this Circular.

3. Validity period of the Animal Disease Safety Facility Certificate: five (5) years from the date of issuance.

4. Facilities wishing to convert a Certificate issued by the District Animal Health Office to a Certificate issued by the Department of Animal Health shall proceed as follows:

a) Submit one (1) set of application files directly or send via postal service or email to the Department of Animal Health, including: Application form (Appendix VIa) or request letter for village-level livestock farms (Appendix VIb); monitoring report confirmed by the District Animal Health Office (for breeding facilities and aquaculture); copies of test results, inspection records of the Evaluation Team, and previously issued Certificates;

b) Within three (3) working days from the date of receiving valid applications, the Department of Animal Health will review the contents of the application and issue a new Certificate to facilities meeting the requirements. The validity period of the newly issued Certificate will be equivalent to the remaining period of the Certificate previously issued by the District Animal Health Office. In cases where a Certificate is not issued, the Department of Animal Health must provide a written response specifying the reasons and guiding the facility on how to address the non-compliant elements.

Article 32. Re-evaluation

1. Facilities with inspection results not meeting the requirements as stipulated in Clause 1, Article 31 or Clause 3, Article 43 of this Circular, or whose Certificates have expired as specified in Point d, Clause 1, Article 47 of this Circular, if they wish to apply for a Certificate, the facility owner or the Chairman of the People's Committee of the commune shall submit one (1) set of application files directly or send via postal service or email to the Veterinary Authority. The application includes:

a) Application form (Appendix VIa) or request letter from the Chairman of the People's Committee of the commune for village-level livestock farms (Appendix VIb);

b) Report on addressing non-compliant elements.

2. Within five (5) working days from the date of receiving the application, the Veterinary Authority will check the validity of the application and establish an Evaluation Team as prescribed in Clause 1, Article 29 of this Circular.

3. Within five (5) working days from the date of establishment, the Evaluation Team will conduct inspections and evaluations of non-compliant elements at the facility as prescribed in Clause 2, Article 30 of this Circular.

4. Issue the Certificate as prescribed in Clauses 1, 2, and 3, Article 31 of this Circular.

Section 2

Disease-free zone for terrestrial animals

Article 33. Registration Documents

The People's Committee of the district or province shall prepare registration documents for disease safety certification and submit one (1) set of documents directly or send via postal service or email to the Department of Animal Health. The documents include:

1. Request letter (Appendix VIc).

2. Report on conditions of terrestrial animal disease safety zones (Appendix III).

3. Monitoring report conducted as prescribed in Article 12, disease status as prescribed in Article 13, and veterinary activities as prescribed in Clause 4, Article 10 of this Circular.

Article 34. Acceptance and Processing of Registration Files

Within five (5) working days from the date of receipt of the file, the Animal Health Department shall check the validity and assess the content of the file.

1. In case the file is valid, the Animal Health Department shall establish an Evaluation Team and notify the inspection and evaluation plan to the registering unit.

2. In case the file is invalid, the Animal Health Department shall notify the registering unit in writing to amend, supplement, and complete the file.

Article 35. Composition of the Evaluation Team and Evaluation Period

1. The Evaluation Team shall consist of at least five (5) members. The team leader shall be a representative of the leadership of the Animal Health Department or the leadership of the specialized department of the Animal Health Department; members shall be leaders and specialized staff of the regional animal health agency, specialized centers under the Animal Health Department, district animal health agencies, and other related units.

2. Within ten (10) working days from the date of establishment, the Evaluation Team must conduct inspections and evaluations in the region.

Article 36. Content of Inspection and Evaluation in the Region

1. Implement disease prevention and control measures as stipulated in Article 11 of this Circular and manage animal health activities in the region as prescribed in Clause 4 of Article 10 of this Circular.

2. Results of monitoring activities as prescribed in Article 12 of this Circular.

3. Collect samples for testing at the designated laboratory to ensure disease safety. The test result report shall be supplemented into the registration file for disease-free zone certification by the Animal Health Department.

4. The inspection results shall be reflected in the Inspection Report of the Evaluation Team as prescribed in Appendix Ib issued together with this Circular.

Article 37. Issuance of Certificate

1. Within fifteen (15) working days from the date of receiving the test results of the designated laboratory and based on the inspection results of the Evaluation Team as prescribed in Clause 4 of Article 36 of this Circular, the Animal Health Department shall issue a certificate to regions meeting the requirements; in case of non-issuance, the Animal Health Department must respond in writing, stating the reasons and guiding the region to rectify the unmet requirements.

2. The validity period of the animal disease-free zone certificate: five (5) years from the date of issuance.

3. The certificate shall be issued according to the model prescribed in Appendix X issued together with this Circular. In case the importing country has different requirements, the Animal Health Department shall adjust the contents of the certificate to meet the importing country's requirements.

Article 38. Re-evaluation

1. Livestock regions that fail to meet the requirements as stipulated in Clause 1 of Article 37 or Clause 3 of Article 43 of this Circular, or have certificates that have expired as stipulated in Point d of Clause 1 of Article 47 of this Circular, if they wish to apply for a certificate, the People's Committee of the district or province shall submit one (1) set of files directly or send them via postal service or email to the Animal Health Department. The file includes:

a) Request letter (Appendix VIc);

b) Report on the results of rectifying the unmet requirements.

2. Within five (5) working days from the date of receipt of the file, the Animal Health Department shall check its validity and establish an Evaluation Team as prescribed in Clause 1 of Article 35 of this Circular.

3. Within seven (7) working days from the date of establishment, the Evaluation Team shall conduct inspections and evaluations of the unmet requirements in the region as prescribed in Article 36 of this Circular.

4. Issue the certificate as prescribed in Article 37 of this Circular.

Section 3

Disease-free zone for aquatic animals

Article 39. Registration file, acceptance and processing of registration files

1. The representative of the region shall prepare the registration file for the issuance of the Disease Safety Certificate and submit one (1) set of the file directly or send it via postal service or email to the Department of Animal Health. The file includes:

a) Request letter (Annex VId);

b) Report on animal aquatic disease safety zone conditions (Annex VII for each facility; accompanied by floor plans, locations of facilities, and descriptions of the common water supply and drainage system in the region);

c) Monitoring results report as stipulated in Article 26 of this Circular, along with copies of reports from each facility within the region.

2. Acceptance and processing of files shall be carried out in accordance with the provisions of Article 34 of this Circular.

Article 40. Composition of the Evaluation Team, Time and Content of Inspection and Evaluation in the Region

1. Composition of the Evaluation Team, evaluation time: As stipulated in Article 35 of this Circular.

2. Content of inspection and evaluation in the region:

a) Implementation of disease prevention and control measures as stipulated in Article 23 of this Circular and management of veterinary activities in the region as stipulated in Clause 4 of Article 22 of this Circular;

b) Results of monitoring activities as stipulated in Article 25 of this Circular;

c) During the inspection process, if signs of disease are found in aquatic animals, the Evaluation Team will take samples and send them to the designated laboratory for testing.

3. The inspection results are recorded in the inspection report of the Evaluation Team as specified in Annex VIIIc issued together with this Circular.

Article 41. Issuance of the Certificate

1. Within fifteen (15) working days from the date of completion of the inspection in the region, the Department of Animal Health issues the Certificate to regions meeting the requirements; in cases where the Certificate is not issued, the Department of Animal Health responds in writing, stating the reasons and providing guidance for the region to address the unmet requirements.

2. Validity period of the Aquatic Animal Disease Safety Zone Certificate: Five (5) years from the date of issuance.

3. The model of the Certificate is as prescribed in Annex X issued together with this Circular. In cases where the importing country has different requirements, the Department of Animal Health adjusts the contents of the Certificate to meet the requirements of the importing country.

Article 42. Re-evaluation

1. Regions raising aquatic animals that fail to meet the requirements as stipulated in Clause 1 of Article 41 or Clause 3 of Article 43 of this Circular, or regions with expired Certificates as stipulated in Point d Clause 1 of Article 47 of this Circular, which wish to apply for the issuance of a new Certificate, shall submit one (1) set of the file directly or send it via postal service or email to the Department of Animal Health. The file includes:

a) Request letter (Annex VId);

b) Report on the results of rectifying the unmet requirements.

2. Within five (5) working days from the date of receipt of the file, the Animal Health Department shall check its validity and establish an Evaluation Team as prescribed in Clause 1 of Article 35 of this Circular.

3. Within seven (7) working days from the date of establishment, the Evaluation Team conducts inspections and evaluations of non-compliant contents in the region as stipulated in Clause 2 of Article 40 of this Circular.

4. Issuance of the Certificate in accordance with Article 41 of this Circular.

Chapter V

MAINTENANCE AND MANAGEMENT OF DISEASE SAFE ZONES AND FACILITIES

Article 43. Periodic and Ad-hoc Evaluations

1. Annually, the Veterinary Authority shall develop and implement a plan to conduct one (1) evaluation for regions and facilities that have been issued a Disease Safety Certificate, specifically as follows:

a) Evaluation content as stipulated in Article 30 or Article 36 or Clause 2 of Article 40 of this Circular;

b) Evaluation results are recorded in the inspection report of the Evaluation Team.

2. Ad-hoc evaluation: The Veterinary Authority establishes an Evaluation Team when there is a risk of disease outbreak or spread in a disease-safe region or facility.

3. If errors affecting disease safety control are discovered, the Evaluation Team shall issue a letter requesting the facility, the People's Committee of the district or province (for terrestrial animal disease-safe zones), or the regional representative (for aquatic animal disease-safe zones) to take corrective actions and specify deadlines. If the errors are not corrected within the specified timeframe, the Disease Safety Certificate becomes invalid as stipulated in Point d Clause 1 of Article 47 of this Circular, and the Veterinary Authority will publish a list of regions and facilities with expired Certificates.

Article 44. Reissuing the Certificate

1. At least three (3) months before the expiry date of the Certificate, the owner of the facility, the Chairman of the People's Committee at the commune level (for safe disease communes for animal husbandry); the People's Committee at the district or provincial level (for terrestrial animal disease-safe zones), or the Representative of the zone (for aquatic animal disease-safe zones) who wish to apply for reissuance of the Certificate shall prepare and submit one (1) set of application documents directly or send them via postal service or email to the Veterinary Authority. The application includes:

a) Application form (Annex VIa) or request letter (Annex VIb, VIc, or VId);

b) Report on activities during the period specified in the Certificate, including: Quantity of breeds imported and exported within the zone or facility; annual livestock product sales volume for each season or batch; veterinary activity report within the facility or zone; vaccination disease prevention results (for terrestrial animal husbandry zones or facilities);

c) Disease surveillance report within the zone or facility; copy of test results from designated laboratories, and the Sanitary Inspection Certificate;

d) Copy of periodic assessment results as stipulated in Clause 1, Article 43 of this Circular (if applicable).

2. Within five (5) working days from receipt of the application, the Veterinary Authority will check the validity and review the content of the application:

a) In cases where the zone or facility has been periodically assessed and the assessment period does not exceed twelve (12) months (counting from the expiry date of the Certificate): Within two (2) working days from completing the review of the application, based on the periodic assessment results, the Veterinary Authority will consider reissuing the Certificate to the zone or facility without the need to establish an Assessment Team;

b) In cases where the zone or facility has not been periodically assessed or has been assessed but the assessment period exceeds twelve (12) months counting from the expiry date of the Certificate: Within two (2) working days from completing the review of the application, the Veterinary Authority will establish an Assessment Team according to Clause 1, Article 29 or Clause 1, Article 35 of this Circular.

3. The Assessment Team proposes the content to be assessed to the Veterinary Authority for consideration and approval.

4. Within five (5) working days from establishment, the Assessment Team conducts inspections and assessments at the zone or facility.

5. Within two (2) working days from the completion of the inspection and assessment, the Assessment Team submits a report with minutes to the Veterinary Authority.

6. Within three (3) working days, based on the assessment results and recommendations of the Assessment Team, the Veterinary Authority issues or does not issue the Certificate to the zone or facility.

7. The validity and format of the Certificate are regulated in Clause 2 and Clause 3, Article 31 or Clause 2 and Clause 3, Article 37 of this Circular.

Article 45. Issuing a New Certificate

1. Zones or facilities holding damaged, worn-out, or lost Certificates wishing to obtain a new Certificate shall submit an Application Form (Annex VIa) or request letter (Annex VIb, VIc, or VId) directly or via postal service or email to the Veterinary Authority.

2. Within two (2) working days from receiving the application, the Veterinary Authority will issue a new Certificate to the zone or facility.

3. The newly issued Certificate retains the original number, issuance date, and all information recorded in the previously issued Certificate.

Article 46. Supplementing the Content of Disease Safety Certification

1. Areas and facilities that have been issued a Certificate of Disease Safety for Animals and wish to supplement additional diseases to be certified as disease-safe must implement the following:

a) For animal husbandry facilities and village-level animal husbandry facilities: Implement the provisions set forth in Articles 8 and 9 of this Circular;

b) For land-based animal husbandry areas: Implement the provisions set forth in Articles 11 and 12 of this Circular;

c) For breeding facilities and aquaculture farms: Implement the provisions set forth in Articles 16, 17, 18, 19, 20, and 21 of this Circular;

d) For aquaculture areas: Implement the provisions set forth in Articles 24, 25, and 26 of this Circular.

2. Registration, acceptance, processing of applications, and evaluation for land-based animal husbandry areas:

a) Application forms: Implement the provisions set forth in point a and point c, Clause 1, or point a and point c, Clause 2, Article 27, or Clause 1 and Clause 3, Article 33 of this Circular;

b) Acceptance and processing of applications: Implement the provisions set forth in Article 28 or Article 34 of this Circular;

c) Composition of the Evaluation Team and evaluation period: Implement the provisions set forth in Article 29 or Article 35 of this Circular;

d) Inspection content: Implement the provisions set forth in Clause 1, Article 30, or Clauses 2, 3, and 4, Article 36 of this Circular.

3. Registration, acceptance, processing of applications, and evaluation for breeding facilities, aquaculture farms, and aquaculture areas:

a) Application forms: Follow the provisions set forth in point a and point c, Clause 1, Article 27, or point a and point c, Clause 1, Article 39 of this Circular;

b) Acceptance and processing of applications: Follow the provisions set forth in Article 28 or Article 34 of this Circular;

c) Composition of the Evaluation Team and evaluation period: Follow the provisions set forth in Article 29 or Article 35 of this Circular;

d) Inspection content: Implement the provisions set forth in Clause 1, Article 30, or Clauses 2 and 3, Article 40 of this Circular.

4. Issuing the Disease Safety Certificate:

a) Within five working days from the date of completion of the inspection at the area or facility or from the date of receipt of the test results for the disease according to Clause 4, Article 30, or Clause 3, Article 36 of this Circular, the Veterinary Authority shall issue the Certificate to the area or facility that meets the requirements. In case the Certificate is not issued, the Veterinary Authority must provide a written response detailing the reasons and guidance on how to rectify the non-compliant aspects;

b) The model of the Certificate and its validity period shall be implemented according to the provisions set forth in Clause 2 and Clause 3, Article 31, or Clause 2 and Clause 3, Article 37 of this Circular.

Article 47. Expiry of the Certificate

1. The Certificate for disease-safe areas and facilities will expire under one of the following circumstances:

a) Five years from the date of issuance;

b) The occurrence of a disease or the detection of pathogens in the area or facility that has been certified as disease-safe;

c) Failure to conduct monitoring and sampling in accordance with the provisions set forth in point a, Clause 3, Article 50 of this Circular;

d) Failure to rectify errors as prescribed in Clause 3, Article 43 of this Circular;

đ) The area or facility being dissolved or ceasing operations.

2. Areas and facilities whose Certificates have expired according to point a, Clause 1 of this Article and wish to apply for a new Certificate shall follow the provisions set forth in Article 44 of this Circular.

3. Areas and facilities whose Certificates have expired according to points b and c, Clause 1 of this Article and wish to apply for a new Certificate shall proceed as follows:

a) Conduct monitoring in accordance with point b, Clause 2, Article 18 of this Circular;

b) Submit one complete application directly or send it via postal service or email to the Veterinary Authority. The application includes: An application form (Annex VIa) or a request letter (Annex VIb, VIc, or VId); A report on the implementation of the provisions set forth in Clause 3 of one of Articles 9, 13, 16, and 24 of this Circular; copies of test results;

c) Within three working days from the date of receiving a complete and valid application, the Veterinary Authority shall review the content of the application and establish an Evaluation Team according to the provisions set forth in Clause 1, Article 29, or Clause 1, Article 35 of this Circular. Within five working days from the date of establishment, the Evaluation Team must conduct inspections and evaluations at the area or facility;

d) Inspection content: The current health status of animals; the implementation of measures to control and prevent disease risks from both external and internal sources within the area or facility; the results of monitoring activities;

đ) During the inspection process, samples shall be taken and sent to the designated laboratory for testing the registered disease (for land-based animal husbandry areas). The test result report provided by the Veterinary Authority shall be included in the application for certification of disease safety for the area or facility. For breeding and aquaculture areas, if diseased aquatic animals or unsatisfactory hygiene conditions are found, the Evaluation Team shall take samples and send them to the designated laboratory for testing;

e) Within five working days from the date of completing the inspection at the area or facility or from the date of receiving the test results for the disease according to point đ, Clause 3 of this Article, the Veterinary Authority shall issue the Certificate to the area or facility that meets the requirements. If the Certificate is not issued, the Veterinary Authority must provide a written response detailing the reasons and guidance on how to rectify the non-compliant aspects;

g) The model of the Certificate and its validity period shall be implemented according to the provisions set forth in Clause 2 and Clause 3, Article 31, or Clause 2 and Clause 3, Article 37 of this Circular.

4. Areas and facilities whose Certificates have expired according to point d, Clause 5 of this Article and wish to apply for a new Certificate shall follow the provisions set forth in Article 32, Article 38, or Article 42 of this Circular.

Chapter VI

RESPONSIBILITIES OF THE RELATED PARTIES

Article 48. Veterinary Bureau

1. Organize the assessment, inspection, evaluation, and issuance of Disease Safety Zone and Facility Certificates in accordance with Clause 1, Article 3 of this Circular.

2. Guide, inspect, supervise the implementation of assessments, inspections, evaluations, and certificate issuances by Provincial Veterinary Services in accordance with Clause 2, Article 3 of this Circular.

3. Announce the list of Disease Safety Zones and Facilities that have been issued or reissued certificates; the list of zones and facilities whose certificates have expired on the Veterinary Bureau's electronic information website (website).

4. Manage Disease Safety Zones and Facilities that have been issued certificates.

5. Safeguard and retain records related to registration, inspection, evaluation, assessment, and recognition of Disease Safety Zones and Facilities.

6. Organize professional training and instruction on inspection, evaluation, and certification of Disease Safety Zones and Facilities.

7. Guide, inspect Disease Safety Zones and Facilities, including sampling for animal disease surveillance.

Article 49. Provincial Veterinary Service

1. Organize the assessment, inspection, evaluation, and issuance of Disease Safety Facility Certificates in accordance with Clause 2, Article 3 of this Circular.

2. Implement guidance and directives from the Veterinary Bureau during the assessment, inspection, evaluation, and issuance of certificates.

3. Announce the list of Disease Safety Facilities that have been issued or reissued certificates; the list of facilities whose certificates have expired on the Provincial Veterinary Service's website (if available) or through local media channels.

4. Manage Disease Safety Facilities that have been issued certificates.

5. Safeguard and retain records related to registration, inspection, evaluation, assessment, and recognition of Disease Safety Facilities.

6. Guide and support zones and facilities in implementing the provisions of this Circular.

7. Report to the Veterinary Bureau:

a) Cases exceeding authority to handle or lacking regulations;

b) The list of Disease Safety Facilities that have been issued or reissued certificates, the list of facilities whose certificates have expired in the locality.

Article 50. Disease Safety Zones and Facilities

1. Comply with approved disease surveillance plans and guidelines.

2. Facilitate conditions for competent authorities to conduct supervision, assessment, evaluation, inspection, and audit at zones and facilities.

3. Maintain zone and facility conditions after being certified:

a) Implement the disease surveillance plan for diseases covered by the safety certificate, including collecting samples at least once every year and sending them for testing at designated laboratories;

b) Adhere to regulations concerning disease prevention and control within zones and facilities;

c) Report changes related to certified contents to the veterinary authority within ten days of the change occurring.

4. Timely notify and cooperate with competent authorities to address import requirements.

5. For cases where applications are submitted via email, after completing the application according to the veterinary authority’s comments, the facility owner resubmits the original application in compliance with this Circular's provisions to the veterinary authority.

6. Pay actual costs incurred in implementation in accordance with the Ministry of Finance's regulations.

Chapter VII

IMPLEMENTING PROVISIONS

Article 51. Transfer

1. For facilities that have been issued an Animal Disease Safety Certificate by the Veterinary Bureau: Continue to maintain disease safety conditions in accordance with the guidance of the Veterinary Bureau and as stipulated in Chapter V and Clause 3 of Article 50 of this Circular.

2. Upon expiration of the validity period of the issued certificate, the facility shall re-register for issuance according to the provisions of Article 44 of this Circular.

Article 52. Effectiveness and Responsibility for Implementation

1. This Circular takes effect from July 19, 2016.

2. This Circular replaces the following documents:

a) Decision No. 66/2008/QD-BNN dated May 26, 2008 of the Ministry of Agriculture and Rural Development promulgating regulations on animal disease safety zones and facilities;

b) Article 3 of Circular No. 20/2011/TT-BNNPTNT dated April 6, 2011 of the Ministry of Agriculture and Rural Development amending and supplementing certain administrative procedures in the veterinary sector pursuant to Resolution No. 57/NQ-CP dated October 15, 2010.

3. During implementation, if there are any difficulties or need for amendments or supplements, relevant agencies, organizations, and individuals shall promptly report to the Ministry of Agriculture and Rural Development for consideration and resolution./.